November 11, 2015
TO: JPA Members
FROM: Patricia Faison
JPA Regulatory Update: FDA Requests Comments on the "Natural" Term - Hogan Lovells Memorandum; Hogan Lovells Memorandum - FDA Final Guidance on IND Requirement for Human Research Studies; Recall of Unpasteurized Apple Juice; Senate Committee Hearing on Dr. Califf's Nomination as FDA Commissioner
FDA Requests Comments on the "Natural" Term - Hogan Lovells Memorandum
Yesterday, JPA staff notified members that the Food and Drug Administration (FDA) had announced the Agency is soliciting comments and information regarding use of the term "natural" on food labels. Today, the FDA published the Federal Register notice (80 FR 69905), which can be accessed here.
JPA's legal counsel, Hogan Lovells, has a published a memorandum, available here, providing additional details on this issue.
The deadline to submit comments to the Agency is February 10, 2016. As noted in JPA's communications of November 10, if you believe JPA should submit comments to the FDA, please provide your detailed input to me by the close of business on December 11, 2015.
Hogan Lovells Memorandum - FDA Final Guidance on IND Requirement for Human Research Studies
In December 2013, a memorandum prepared by Hogan Lovells summarizing the impact of the FDA’s final guidance, “Investigational New Drug Applications (INDs) – Determining Whether Human Research Studies Can Be Conducted Without an IND (IND Guidance)” on the food industry was shared with JPA members. On October 30, 2015, the FDA issued a Federal Register notice (80 FR 66907), available here, announcing the Agency received a number of comments regarding the final guidance and as such, it is staying part of the final guidance to allow the Agency to further consider the issues raised. The FDA has reissued the guidance, available here, with the portions that are being stayed identified so interested parties can distinguish those sections that remain in effect from those sections that are subject to the stay.
Hogan Lovells has prepared a memorandum, available here, which summarizes the key provisions of the Federal Register notice and impact on conventional foods.
Recall of Unpasteurized Apple Juice
According to an article recently published on FoodSafetyNews.com, available here, thirteen cases of Escherichia coli (E. coli) O111 infection linked to unpasteurized apple juice produced by High Hill Ranch [Camino, California] have been confirmed as of November 6, 2015. High Hill Ranch initiated a recall of its brand of unpasteurized apple juice on October 23, 2015. The article notes state and county health and environmental agencies are investigating the source of the problem.
Senate Committee Hearing on Dr. Califf's Nomination as FDA Commissioner
In September 2015, JPA members were notified that President Barack Obama had nominated Dr. Robert Califf to replace Dr. Margaret Hamburg as FDA Commissioner. Dr. Califf is currently FDA's Deputy Commissioner for Medical Products and Tobacco. According to the November 11, 2015 edition of Food Chemical News, the Senate Health, Education, Labor and Pensions Committee will consider the nomination during a hearing on November 17, 2015. Dr. Califf's nomination must be confirmed by the Senate.
JPA will continue to monitor and provide updates, as information becomes available.
As always, please contact me with questions or comments.
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